Description

QA Management

Manage the electronic Document Management system, produce documentation such as SOP's, WI's, Doc's etc. Liaise with QA Consultant on the same. (includes work on ISO14001, OHSAS18001 and ISO27001 systems)
Perform and manage internal QA audits if and when required. Maintain audit records as well as CAPA.
Manage supplier records in the Approved Supplier Database (ASD), process supplier renewals. Escalate potential issues to the RA/QA Manager
Manage/approve product records in the Product Registration Database (PRS)
Manage, monitor and progress complaints. Liaise with Service Dept, BU and various TMSE counterparts to effect progress.
Escalate 'hot' complaints to the Manager Regulatory Affairs and QA
Assist with carrying out risk assessments on new business processes and ventures using Quality techniques such as FMEA, Fishbone diagrams, Cause and Effect matrices, Pareto charts
Perform Root Cause analysis using suitable techniques - carry out training to staff on the same

Regulatory Affairs

Assist with running the various compliance schemes (Anti-Bribery, EU Competition Law, Data Protection etc)
Provide employee introductions for the various schemes
Prepare e-training assignments, monitor completion and chase.
Assist with implementation of corporate programs as under 1).
Ensure training records are maintained
Prepare annual reports for the above together with the Manager Regulatory Affairs and QA
Responsible for annual and quarterly submissions of WEEE and Battery Data to Environment Agency/Compliance Scheme(s). Liaise with TMSE on the above.
Respond to QA and RA queries in commercial tenders and questionnaires in a timely manner.

Experience/Skills Required
- Good general standard of education, with excellent written and spoken English, preferably to degree level.
- A working knowledge of the various standards certified as an internal auditor for ISO9001 and ISO13485
- A technical background is desirable to allow ready understanding of engineering principles and working practices.
- Ability to train/instruct people either one to one or class room based
- Good Numeracy
- Excellent MS Excel skills
- Prepared to travel occasionally to various location within the UK, as well as abroad

Company Name:

Lawrence Harvey

Headquarters:

150 Leadenhall Street,London

Sector:

Staffing Firms

Country:

United Kingdom

Zipcode:

EC3V4TE

Website:

www.lawrenceharvey.com

Employees:

100 - 499

Industry:

Pharmaceutical Recruitment

City:

London

Phone No. :

0203 327 3072

Lawrence Harvey Life Sciences has exceptional relationships with the top talent and leading organisations in the Pharmaceutical and Medical Devices industry across the UK, USA, DACH region and the rest of Europe. Our consultants are experts within their specific areas and have a deep understanding of the full Life Sciences developmental cycle. As a client with a challenging role or a candidate with a niche specialism, you will receive a consultative service from people who truly understand the expectations and requirements of your industry.
In an ever developing industry, an in-depth technical understanding and knowledge adds significant value and is imperative to ensuring our consultants are always up to speed, positioning ourselves perfectly to offer advice, analysis and support to our clients and candidates.
We partner with leading pharmaceutical, medical device, generics, biotechnology, clinical research, R&D, manufacturing, regulatory affairs, CRO’s, CMO’s and medical communications organisations and have acquired an enviable and unrivalled reputation for delivering on niche, hard to fill and challenging positions.
Our Specialisms within Life Sciences:
Pharmaceuticals
Medical Devices
Regulatory Affairs
Quality Assurance
Quality Control
Engineering
Medical Affairs / Medical Information
Qualified Persons
Drug safety & Pharmacovigilance
Biostatistics
Clinical SAS
Medical Writing
Account Management & Business Development